DESCRIPTION
id: d218ce99-0f9c-41f9-9aca-7a7cef62d069
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets for oral administration contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended-release. Tablets also contain as excipients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, silicon dioxide, hypromellose and polyethylene glycol.
Fexofenadine hydrochloride, one of the active ingredients, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride and the following chemical structure:
The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl. Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.
Pseudoephedrine hydrochloride, the other active ingredient, is an adrenergic (vasoconstrictor) agent with the chemical name [S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzenemethanol hydrochloride and the following chemical structure:
The molecular weight is 201.70. The molecular formula is C10H15NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform.
INDICATIONS AND USAGE
id: 1f758e23-32ba-423d-afe2-f7d773caba09
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).
CONTRAINDICATIONS
id: f6cca6f5-e46c-48f3-bd94-faf8732a1f9c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients.
Due to its pseudoephedrine component, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see Drug Interactions section). It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.
WARNINGS
id: adf6a951-ebbe-43aa-bc57-d922cf3d664d
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see CONTRAINDICATIONS). Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.
OVERDOSAGE
id: 838c7e9a-b166-4838-8a2f-de0d897981e6
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Most reports of fexofenadine hydrochloride overdose contain limited information. However, dizziness, drowsiness, and dry mouth have been reported. For the pseudoephedrine hydrochloride component of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, information on acute overdose is limited to the marketing history of pseudoephedrine hydrochloride. Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy volunteers at this dose level), and doses up to 690 mg twice daily for one month (3 healthy volunteers at this dose level), were administered without the development of clinically significant adverse events.
In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure.
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood (up to 1.7% removed). The effect of hemodialysis on the removal of pseudoephedrine is unknown.
No deaths occurred in mature mice and rats at oral doses of fexofenadine hydrochloride up to 5000 mg/kg (approximately 170 and 340 times, respectively, the maximum recommended human daily oral dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets on a mg/m2 basis.) The median oral lethal dose in newborn rats was 438 mg/kg (approximately 30 times the maximum recommended human daily oral dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets on a mg/m2 basis). In dogs, no evidence of toxicity was observed at oral doses up to 2000 mg/kg (approximately 450 times the maximum recommended human daily oral dose on a mg/m2 basis). The oral median lethal dose of pseudoephedrine hydrochloride in rats was 1674 mg/kg (approximately 55 times the maximum recommended human daily oral dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets on a mg/m2 basis).
DOSAGE AND ADMINISTRATION
id: 29920741-a71d-4578-8274-1942c66dc291
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The recommended dose of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function. (See CLINICAL PHARMACOLOGY and PRECAUTIONS.)
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets may be eliminated in the feces in a form that may resemble the original tablet. (See PRECAUTIONS, Information for Patients.)
HOW SUPPLIED
id: 3dbc21af-bedb-4404-95ca-567fa074183f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are available in bottles of 14 (NDC 21695-820-14).
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are two-layer tablets, one white layer and one tan layer with a clear film coating on the tablets. The tablets are engraved with “W07” on the white layer.
Store Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)
Rev. June 2009
Winthrop U.S.
a business of sanofi-aventis U.S. LLC.
Bridgewater, NJ 08807
©2009 sanofi-aventis U.S. LLC
50090971
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL – 60/120 mg Tablet Bottle
id: 9dbfd325-cf1f-4fd2-be69-d339399e70bb
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
